PRA has a strong strategic presence in the Central and Eastern European (CEE) countries of Poland, Hungary and the Czech and Slovak Republics. PRA has been executing our unique Unit on Demand model for patient studies in this region with great success for numerous years.
The Unit on Demand model is based on the use of hospital-based patient populations for Phase I-IIa studies. The Phase I study is conducted in a specialist hospital with direct access to the required patient population. The studies are coordinated and managed by experienced PRA project managers.
PRA’s Unit on Demand model specializes in Proof-of-Concept in the following study types:
- Phase I studies in special patient populations, primarily PK studies in patients with impaired hepatic or renal function
- Phase I–IIa studies in:
- Endocrinology (i.e., Diabetes Mellitus, obesity)
Our CEE group provides a number of advantages for your EDS studies including:
- The groundbreaking Unit on Demand model for patient studies
The Unit on Demand model uses specialist hospital based patient populations in CEE for Phase I studies (patients can be enrolled rapidly). Studies are designed, setup and conducted (including recruitment from specialist patient populations) inside the hospital by dedicated PRA experts under GCP guidelines with the patients under the care of their own physicians throughout. Direct access to the patient population is maintained at all times during the study allowing complex monitoring procedures to be used as routine.
Advantages of Unit on Demand include:
- Patient recruitment rate 10 times greater than traditional programs
- Significant savings in cost and time
- Extensive monitoring and testing in dedicated units
- Exclusive access to hospital-based patient populations for Phase I-IIa studies
- Patients are under their own medical care while PRA staff conduct on-site study
- The Prague and Budapest centers having two dedicated units with 12 and 8 beds respectively
- Specializes in proof-of-concept studies in a wide range of clinical areas including:
- Infectious diseases (hepatitis C)
In CEE our centers have particular expertise in PK studies for hepatically or renally impaired patients.